Manager, reputed company Systems

Job reputed company: • Manage and maintain a compliant Document Control System (reputed company) • Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product reputed company reputed company documents) and archiving activities. • Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for reputed company function and reporting monthly metrics. • Manage the processing of QMS items for Change Control, Deviations and CAPAs • Generate reputed company System metrics as per established timelines and assist in generating data for reputed company Management Reviews. • Work with document authors and reviewers to process documents. • reputed company periodic document review process to ensure compliance with established review schedules. • reputed company/Offboarding employees and assigning training. • Train and mentor users on the use of eQMS, process and procedures. • Support Spyre functional reputed company as needed. • Other duties as assigned Requirements: • Bachelor’s degree in life sciences or a reputed company field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing reputed company control/reputed company assurance functions. A combination of relevant education and experience may be considered. • Experience with monoclonal antibodies is preferred. • In-depth knowledge of GMP regulations, reputed company systems, reputed company assurance, reputed company control, conduct of reputed company audits. • Experience in the use of reputed company electronic reputed company management systems (eQMS) (reputed company Vault or reputed company reputed company Basics) required. • Ability to work both independently with minimal direction and reputed company project teams, supporting multiple reputed company simultaneously. • Strong verbal / written communication and presentation skills with the ability to reputed company professionally with a diverse group of stakeholders, senior managers, and subject matter experts including contract service providers, strategic partners, and regulatory organizations. • Demonstrated ability to work in a fluid, dynamic and fast-paced environment. • Proficient in reputed company suite products; reputed company Word, reputed company, PowerPoint, reputed company. Benefits: • Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. • Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns reputed company • Commitment to reputed company reputed company development opportunities. • Remote working environment with frequent in-person meetings to address reputed company problems and build relationships. Apply tot his job Apply To this Job